Actos Lawsuit Slams Takeda Pharmaceutical Executives

Boston, MAA whistleblower lawsuit filed against Takeda Pharmaceuticals alleges the maker of Actos ignored concerns about potential Actos side effects, including Actos and bladder cancer, and actively promoted the use of Actos for treatment of prediabetes. A type 2 diabetes drug, Actos (pioglitazone hydrochloride) was never approved by the US Food and Drug Administration (FDA) for treating prediabetes.

According to court documents, the whistleblower in the Actos lawsuit is Peter P. Lawton, formerly the director of patent life-cycle maximization at GlaxoSmithKline (GSK). Having left GSK’s employ in 2003 after a 20-year career with the UK pharmaceutical giant, Lawton alleges he was privy to information during a series of three job interviews with Takeda in 2009. Lawton is reported to have told a Massachusetts federal court earlier this year that Takeda executives claimed to have been paying off doctors to prescribe Actos for treatment of prediabetes.

Lawton also alleges that Takeda and its marketing partner at the time, Eli Lilly, made payments to doctors in exchange for the undertaking of so-called educational presentations and sessions touting the scientifically-proven benefits of Actos.

It is alleged that studies used for these sessions were written by Takeda.

Actos is a popular medication for the treatment of type 2 diabetes, at one time lagging behind sales of GSK’s Avandia before the latter fell from favor over allegations of cardiovascular issues. Actos also carries risk for Actos heart failure, but not to the degree of Avandia and thus was considered a safer alternative. Sales of Actos spiked dramatically.

Over the ensuing years, plaintiffs have accused Takeda of minimizing or withholding evidence of bladder cancer - saying that had they known about the alleged association between Actos and bladder cancer, they would have lobbied to be on a different type 2 diabetes drugs.

Lawton, who launched his whistleblower lawsuit in February 2014 and continues on his own after the federal government declined to join, alleges that Takeda executives told him they had prior knowledge that the FDA would not be approving Actos for prediabetes. And yet, according to the lawsuit, Takeda and Eli Lilly proceeded to pay up to 1,000 doctors and other medical professionals between $2,000 and $3,000 per presentation to promote off-label use of Actos.

While doctors have the legal and ethical freedom to prescribe medications off label, manufacturers do not. It is illegal for a manufacturer to actively promote and market a drug for indications for which it was not formally approved by the FDA.

The activities and conduct that lay at the root of the Actos lawsuit allegedly occurred between 2000 and 2011. “Without defendants’ off-label marketing campaign, few if any doctors would have prescribed Actos to healthy patients for the prevention of diabetes,” the lawsuit contends.

The lawsuit is Lawton v. Takeda Pharmaceuticals Inc., Case No. 1:12-cv-10797 in US District Court for the District of Massachusetts.